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Multicenter, Randomized, Double-Blind Study Comparing 20 and 40 mg of Pantoprazole for Symptom Relief in Adolescents (12 to 16 Years of Age) with Gastroesophageal Reflux Disease (GERD)

Children’s Hospital of The King’s Daughter, Norfolk, VA

Robert Baker, MD

Children’s Hospital of Buffalo, Buffalo, NY

Linda Book, MD

University of Utah/Primary Children’s Medical Center, Salt Lake City, UT

Abdel-Hai Hammo, MD

Rhode Island Hospital, Providence, RI

Elaine F. Soffer, BS

Wyeth Research, Collegeville, PA

Wenjin Wang, PhD

Wyeth Research, Collegeville, PA

Gail M. Comer, MD

Wyeth Research, Collegeville, PA

Members of the 326 Study Group

An age-appropriate questionnaire (GASP-Q) was used to assess the frequency and severity of the gastroesophageal reflux disease (GERD) symptoms: abdominal/belly pain, chest pain/heartburn, pain after eating, nausea, burping/belching, vomiting/regurgitation, choking when eating, and difficulty swallowing, in adolescents age 12 to 16 years. The primary objective was to compare the mean composite symptom score (CSS) at week 8 with baseline after treatment with 20 or 40 mg of pantoprazole. Statistically significant (p < 0.001) improvement in CSS occurred in both groups. Safety was comparable between the 2 groups. Pantoprazole was safe, well tolerated, and effective in reducing symptoms of GERD in adolescents.

Clinical Pediatrics, Vol. 45, No. 8, 741-749 (2006)
DOI: 10.1177/0009922806292792


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